Henry Kissinger?

For some reason, I never appreciated it until now.

I checked Jim’s X account (@JamesEKrause), and the last time he posted about VKTX was Jun 2023.

More on the same topic:

https://www.wsj.com/livecoverage/stock-market-today-earnings-04-23-2024/card/cleveland-cliffs-counting-on-biden-to-block-u-s-steel-purchase-hUHIUr7P15Rnk93TyUjB

p.s. Today's CLF CC was another one for the ages. It didn't help the share price, but it was great entertainment as well as educational.

I would argue that the two MoAs are more different than similar. Excision Bio’s approach of editing the cccDNA does not rely on the immune system—or on any host response whatsoever.

Yes, in due course. But investors' knee-jerk reaction was negative insofar as more buybacks means more debt (all else being equal).

CLF 1Q24 CC slides:

https://d1io3yog0oux5.cloudfront.net/_3efb7c3d63ae6bae87e3b8ff1637f911/clevelandcliffs/db/1111/11752/file/CLF+-+Q1+2024+Earnings+Presentation.pdf

CLF 1Q24 CC notes re capital allocation:

CLF’s targeted debt leverage is <=2.5x EBITDA. There is ample room for CLF to continue to repurchase shares while staying well below the 2.5x ceiling.

CLF has no debt maturities until 2027.

CLF 1Q24 CC transcript:

https://finance.yahoo.com/news/cleveland-cliffs-clf-q1-2024-170011838.html

Much discussion of the non-takeover of US Steel.

Caution: this transcript has several OCR-generated errors. E.g., the transcript says “gold” in several places where the actual word is GOS (Grain-Oriented [electrical] Steel).

CLF 1Q24 CC transcript:

https://finance.yahoo.com/news/cleveland-cliffs-clf-q1-2024-170011838.html

Much discussion of the non-takeover of US Steel.

Caution: this transcript has several OCR-generated errors. E.g., the transcript says “gold” in several places where the actual word is GOS (Grain-Oriented [electrical] Steel).

CLF 1Q24 CC slides:

https://d1io3yog0oux5.cloudfront.net/_3efb7c3d63ae6bae87e3b8ff1637f911/clevelandcliffs/db/1111/11752/file/CLF+-+Q1+2024+Earnings+Presentation.pdf

CLF 1Q24 CC notes re capital allocation:

CLF’s targeted debt leverage is <=2.5x EBITDA. There is ample room for CLF to continue to repurchase shares while staying well below the 2.5x ceiling.

CLF has no debt maturities until 2027.

Irony? Denmark’s national healthcare system does not reimburse for Wegovy.

Are you planning to tune in?

Will this work?

https://www.globenewswire.com/news-release/2024/04/23/2867508/0/en/Regeneration-Biomedical-Doses-First-Patient-in-a-First-in-Human-Phase-I-Clinical-Trial-of-Stem-Cell-Therapy-delivered-directly-into-the-brain-of-Patients-with-Alzheimer-s-Disease.html

UBX—Beware when a company increases the statistical power of a clinical trial in midstream:

https://www.globenewswire.com/news-release/2024/04/23/2867620/0/en/UNITY-Biotechnology-Announces-Extension-of-Phase-2b-ASPIRE-Clinical-Study-Evaluating-UBX1325-in-DME.html

B-I has_a fusion protein_for NASH that_hits GLP-1/FGF21:

https://www.genengnews.com/news/boehringer-ingelheim-yuhan-launch-up-to-870m-nash-collaboration/

Could be an alternative to combination therapy.

Addendum—This program is very early, but if the MoA works it would rid hepatocytes of HBV cccDNA and thereby cure the disease.

The 1Q24 GAAP loss of $67M includes a $177M mostly-non-cash writedown from idling the Weirton, Ohio plant. This is shown in the GAAP-to-non-GAAP earnings reconciliation table at the bottom of the press release.

Private company attacking HBV via CRISPR-based editing_of_viral_DNA:

https://www.globenewswire.com/news-release/2024/04/22/2867238/0/en/Excision-BioTherapeutics-Announces-Oral-Presentation-Highlighting-Positive-Data-from-its-HBV-Program-EBT-107-at-the-Upcoming-ASGCT-2024-Annual-Meeting.html

ABEO—(-53%/AH)—receives CRL due to CMC issues:

https://finance.yahoo.com/news/abeona-therapeutics-provides-regulatory-pz-200500676.html

CLF reports 1Q24 results—authorizes new $1.5B buyback—reiterates 2024 guidance:

https://www.clevelandcliffs.com/investors/news-events/press-releases/detail/635/cleveland-cliffs-reports-first-quarter-2024-results-and

In 1Q24, CLF repurchased $608M of stock at an average price of $20, reducing shares outstanding by 6% and exhausting the pre-existing $1.0B buyback authorization. As a result, CLF has now authorized a new $1.5B buyback.

1Q24 highlights

• Revenue of $5.2B, -2% YoY

• Steel shipments of 3.94M net tons, -3% YoY

• Adjusted EBITDA of $414M, +70% YoY and +48% QoQ

• 3/31/24 net debt of ~$3.6B, up from $2.9B @12/31/23 (the increase is due primarily to the $608M share buyback)

Re-iterated 2024 guidance

• Steel shipment volumes of 16.5 million net tons, compared to 16.4 million net tons in 2023

• Steel unit cost reductions of approximately $30 per net ton, corresponding to ~$500M adjusted EBITDA benefit compared to 2023

• Capital expenditures of $675 to $725 million

The stock is down slightly in AH trading. CC Tuesday at 8:30am ET.

CLF reports 1Q24 results—authorizes new $1.5B buyback—reiterates 2024 guidance:

https://www.clevelandcliffs.com/investors/news-events/press-releases/detail/635/cleveland-cliffs-reports-first-quarter-2024-results-and

In 1Q24, CLF repurchased $608M of stock at an average price of $20, reducing shares outstanding by 6% and exhausting the pre-existing $1.0B buyback authorization. As a result, CLF has now authorized a new $1.5B buyback.

1Q24 highlights

• Revenue of $5.2B, -2% YoY

• Steel shipments of 3.94M net tons, -3% YoY

• Adjusted EBITDA of $414M, +70% YoY and +48% QoQ

• 3/31/24 net debt of ~$3.6B, up from $2.9B @12/31/23 (the increase is due primarily to the $608M share buyback)

Re-iterated 2024 guidance

• Steel shipment volumes of 16.5 million net tons, compared to 16.4 million net tons in 2023

• Steel unit cost reductions of approximately $30 per net ton, corresponding to ~$500M adjusted EBITDA benefit compared to 2023

• Capital expenditures of $675 to $725 million

The stock is down slightly in AH trading. CC Tuesday at 8:30am ET.

IMMNOV.ST—(+36%)—also_has liquid-biopsy for pancreatic cancer:

https://www.prnewswire.com/news-releases/immunovia-announces-positive-results-from-the-model-development-study-for-its-next-generation-pancreatic-cancer-detection-test-302123066.html

VAXX -37%/AH on voluntary delisting:

https://finance.yahoo.com/news/vaxxinity-announces-intention-voluntarily-delist-202700884.html

Ideal PR for a Friday evening, LOL.

HEPA terminates NASH trial:

https://www.globenewswire.com/news-release/2024/04/19/2866379/0/en/Hepion-Pharmaceuticals-Initiates-Wind-Down-Activities-in-Phase-2b-ASCEND-NASH-Trial.html

I'm going out on a limb and calling this biotech company a scam. $HEPA https://t.co/1EhBQEue5C

— Roy Friedman (@DewDiligence) January 29, 2020

Drug/biotech companies have_qualms_about chatbot security risk:

https://www.fiercepharma.com/marketing/two-thirds-top-20-pharmas-have-banned-chatgpt-and-many-life-sci-call-ai-overrated-survey

Right! ENTA updated the guidance for RSVHR reporting on the Leerink webcast on 3/13/24 (the same date as the “new” corporate slide set). The prior “it depends” guidance was from ENTA’s FY1Q24 CC on 2/7/24.

In any event, the salient point is that ENTA is not due to report any clinical data until July at the earliest. This should reassure anyone who may have thought the recent share-price decline was due to a data leak.

That makes sense (eom).

Article behind paywall. Can you post an excerpt? TIA

What did PACB gain by "hiding" the revenue problem for one quarter?

Re: Double-dose Jeuveau

Thanks for the correction. However, the fact that EOLS published the double-dose Jeuveau data in a little known journal doesn’t change my contention that the dataset has been doctored.

Jeuveau is simply a Korean knockoff of Botox, and there is no mechanistic explanation for why it ought to have a longer duration than Botox or other Botox knockoffs. Reducing the relative amount of diluent, which EOLS did the double-dose Jeuveau study, is something that Botox injectors have experimented with for decades without being able to show a material benefit in duration.

Moreover, doubling the amount of active toxin administered to a fixed region of the face would be expected to produce a higher rate of ptosis, which EOLS’ dataset did not show—a red flag that something is amiss.

IF EOLS’ double-dose Jeuveau data were real, it would be a big breakthrough that would comprise the cornerstone of EOLS’ go-to-market strategy. Instead, EOLS treats the double-dose data as an afterthought and acknowledges that few of its customers will want it.

All told, it’s pretty obvious to me that double-dose Jeuveau is a ploy that EOLS engaged not to further its own business, but rather to create confusion in the marketplace about Daxxify and thereby impede Daxxify’s commercial uptake. On this score alone, EOLS may have been successful in accomplishing what it hoped to accomplish, but the impeding of Daxxify’s uptake will be transient. A year from now, nobody will be talking about double-dose Jeuveau.

Nothing has changed regarding double-dose Jeuveau since the post I'm replying to; it remains a gimmick that has little consequence in the marketplace.

Reply to 'iwfal' on Biotech Values board:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174265867

In other words, EOLS declined to publish what they said they would, which is consistent with what I posited in #msg-173201637.

I stand by everything I said in the above-linked post. To re-iterate: Double-dose Jeuveau is a gimmick; it won't move the needle for Jeuveau to any material degree.

ENTA corporate slide set (3/13/24):

https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4

There are no differences between the 3/13/24 slide set and the previous slide set on 2/7/24.

Clinical newsflow reiteration: ENTA expects to report data from the Zelicapavir RSVPEDs trial and the EDP-938 “challenge” trial in 3Q24. ENTA has not yet commented on when it will report data from the Zelicapavir PSVHR trial (for high-risk adults) because that depends on whether enrollment is completed during the current RSV season in the Northern Hemisphere.